Trial evaluating EphA2-targeted CAR T-cell therapy in recurrent glioblastoma, an urgent and significant unmet medical need with no standard of care treatment option
Anti-EphA2 CAR-T therapy appears to be well-tolerated thus far, based on initial safety data from first patient cohort
Preliminary clinical study results demonstrating persistence of T-cell activity published in the June 2021 issue of the peer-reviewed scientific journal, Frontiers in Oncology
FREEHOLD, N.J., July 01, 2021 (GLOBE NEWSWIRE) -- Avalon GloboCare Corp. (NASDAQ: AVCO) (“Avalon” or “the Company”), a clinical-stage global developer of cell-based technologies and therapeutics, today announced that its planned acquisition target, SenlangBio, has initiated a first-in-human clinical trial evaluating anti-EphA2 chimeric antigen receptor (CAR) T-cell therapy for recurrent glioblastoma. Glioblastoma is the most common type of primary brain tumor and a devastating and aggressive cancer with few treatment options.
SenlangBio’s anti-EphA2 CAR-T is a first-in-class cellular therapy and to our best knowledge, the first ever EphA2-targeted CAR-T with reported clinical trial data. Erythropoietin-producing hepatocellular receptor tyrosine kinase class A2 (EphA2) is a tumor-associated antigen expressed on glioblastoma cells but not on non-cancerous, normal cells of the brain. The anti-EphA2 CAR-T therapy is designed to attack the brain cancer while preserving healthy brain cells.
Currently approved CAR-T therapies have been successful for patients with difficult to treat CD19-positive leukemias and lymphomas. However, prior attempts of treating solid tumor patients with CAR-T therapies have thus far not been shown to be effective. SenlangBio is developing next generation CAR-T therapies for solid tumors by focusing on strategic cancer cell targets such as EphA2 that are specific to cancer cells.
Three patients have received the starting dose of anti-EphA2 CAR-T in this dose-escalation trial. Preliminary clinical trial results were recently published in the June 2021 issue of the peer-reviewed journal Frontiers in Oncology. To date, the therapy has been well-tolerated and the CAR T-cells have demonstrated persistent activity over four weeks after initial dosing in patients.
Prior to initiation of the clinical trial, SenlangBio successfully completed pre-clinical feasibility testing of its anti-EphA2 CAR-T and obtained Institution Review Board (IRB) approval from Xuanwu Hospital, the teaching hospital of Capital Medical University, Beijing, China, where the trial is being conducted (NIH clinical trial registration number: NCT 03423992).
Additional Details About the Senlang Bio Transaction
On June 13, 2021, Avalon entered into a Share Purchase Agreement (the “Purchase Agreement”), by and among Avalon and the other parties named therein to acquire SenlangBio (the “Acquisition”). The Acquisition is subject to the satisfaction of certain conditions to closing set forth in the Purchase Agreement, including approval by the Avalon stockholders of the issuance of the Acquisition Shares pursuant to the rules of the Nasdaq Stock Market (“Nasdaq”) and approval of the listing of the Acquisition Shares by Nasdaq. In connection with the Acquisition, Avalon will prepare and file with the U.S. Securities and Exchange Commission (the “SEC”), a proxy statement and will seek the approval of its stockholders with respect to the issuance of the Acquisition Shares pursuant to Nasdaq rules. Currently, the officers and directors of Avalon own in the aggregate approximately 64.1% of the outstanding shares of Avalon Common Stock and are expected to vote in favor of the issuance of the Acquisition Shares pursuant to Nasdaq rules.
Avalon has filed a Current Report on Form 8-K with the SEC on June 14, 2021 which provides more detail on the terms of the Purchase Agreement and the transactions contemplated thereby and a detailed description of the SenlangBio business. In addition, Avalon filed a Current Report on Form 8-K/A with the SEC on June 28, 2021 which contains historical financial information with respect to SenlangBio and its operations, as well as certain other financial information with respect to the proposed Acquisition.
About Avalon GloboCare Corp.
Avalon GloboCare Corp. (NASDAQ: AVCO) is a clinical-stage, vertically integrated, leading CellTech bio-developer dedicated to advancing and empowering innovative, transformative immune effector cell therapy, exosome technology, as well as COVID-19 related diagnostics and therapeutics. Avalon also provides strategic advisory and outsourcing services to facilitate and enhance its clients' growth and development, as well as competitiveness in healthcare and CellTech industry markets. Through its subsidiary structure with unique integration of verticals from innovative R&D to automated bioproduction and accelerated clinical development, Avalon is establishing a leading role in the fields of cellular immunotherapy (including CAR-T/NK), exosome technology (ACTEX™), and regenerative therapeutics. For more information about Avalon GloboCare, please visit www.avalon-globocare.com.
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Additional Information about the Proposed Acquisition Transaction and Where to Find It
This communication relates to the proposed Acquisition and may be deemed to be solicitation material in respect of the Acquisition. In connection with the Acquisition, Avalon will file relevant materials with the SEC, including a proxy statement on Schedule 14A (the “Proxy Statement”). This communication is not a substitute for the Proxy Statement or for any other document that Avalon may file with the SEC or send to Avalon’s stockholders in connection with the Acquisition. BEFORE MAKING ANY VOTING DECISION, INVESTORS AND SECURITY HOLDERS OF AVALON ARE URGED TO READ THE PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND OTHER DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT AVALON, SENLANGBIO, THE ACQUISITION AND RELATED MATTERS. The Acquisition will be submitted to Avalon’s stockholders for their consideration. Investors and security holders will be able to obtain free copies of the Proxy Statement (when available) and other documents filed by Avalon with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed by Avalon with the SEC will also be available free of charge on Avalon’s website at www.avalon-globocare.com or by contacting Avalon’s Investor Relations contact at PR@Avalon-GloboCare.com.
Participants in the Solicitation
Avalon and its directors and certain of its executive officers and employees may be deemed to be participants in the solicitation of proxies from Avalon’s stockholders with respect to the Acquisition under the rules of the SEC. Information about the directors and executive officers of Avalon and their ownership of shares of Avalon’s common stock is set forth in its Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the SEC on March 30, 2021 and in subsequent documents filed with the SEC, including the Proxy Statement. Additional information regarding the persons who may be deemed participants in the proxy solicitations and a description of their direct and indirect interests in the Acquisition, by security holdings or otherwise, will also be included in the Proxy Statement and other relevant materials to be filed with the SEC when they become available. You may obtain free copies of this document as described above.
Cautionary Notes Regarding Forward-Looking Statements
This communication contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Avalon generally identifies forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar words, including statements regarding SenlangBio and the Acquisition. These statements are only predictions. Avalon has based these forward-looking statements largely on its then-current expectations and projections about future events and financial trends as well as the beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Avalon’s control. Avalon’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to: (i) risks associated with Avalon’s ability to obtain the stockholder approval required to consummate the Acquisition in accordance with Nasdaq rules and the timing of the closing of the Acquisition, including the risks that a condition to closing would not be satisfied within the expected timeframe or at all or that the closing of the Acquisition will not occur; (ii) the outcome of any legal proceedings that may be instituted against the parties and others related to the Purchase Agreement; (iii) the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the Purchase Agreement, (iv) unanticipated difficulties or expenditures relating to the Acquisition, the response of business partners and competitors to the announcement of the Acquisition; and (v) those risks detailed in Avalon’s most recent Annual Report on Form 10-K and subsequent reports filed with the SEC, as well as other documents that may be filed by Avalon from time to time with the SEC. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Avalon cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. The forward-looking statements made in this communication relate only to events as of the date on which the statements are made. Except as required by applicable law or regulation, Avalon undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events.
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